Study Of Sterilization Technologys For Angelicae Sinensis Radix Powder Based On Physicochemical Property And Biological Evaluation

Objective:Chinese materia medica powder（CMMP）is an important intermediate in the preparation of Chinese materia medica.Sterilization of CMMP is an essential key operation unit,which directly affects the safety,effectiveness and quality stability of drugs.The evaluation of its sterilization effect should combine the characteristics of CMMP,adopte a multidimensional quality evaluation and selecte appropriate sterilization methods,the internal quality and sterility of CMMP after sterilization can be guaranteed.Methods:In this study,angelica powder was used as the model drug,The optimum technological parameters of ethanol sterilization and ⁶⁰Co irradiation sterilization were studied.The effects of ethanol sterilization,irradiation sterilization,dry heat sterilization and wet heat sterilization on the inactivation of microorganisms in angelica powder were compared.The study compared the change of physical properties about angelica sinensis raw powder that deal with four kinds of sterilization process before and after such as powder particle size,density,Angle of repose,hygroscopicity,color difference,surface morphology,compared the effects of four sterilization processes of angelica crude powder on ferulic acid content,essential oil composition（ligustilide）,polysaccharide and other main effective components and the bacteriostatic ability of angelica essential oil.In this way,the advantages and disadvantages of sterilization process are comprehensively evaluated,and a multidimensional quality evaluation system based on"physicochemical property and biological evaluation"is established.Results:1.Optimization of ethanol and ⁶⁰Co irradiation sterilization process for angelica crude powderWith the sterilization rate as the index,ethanol dosage,ethanol concentration,sterilization temperature and sterilization time as factors,On the basis of single factor test,response surface method was used to optimize the sterilization process of angelica powder ethanol.The obtained model is significant,and the optimal technological parameters of ethanol sterilization are:ethanol dosage 25%,ethanol concentration 84%,sterilization temperature 70℃,sterilization time 1.5h.Through the investigation of the irradiation dose,the results showed that angelica root powder had a good sterilization effect after irradiation by irradiation.With the increase of irradiation dose,the remaining total number of bacteria,mold and yeast decreased synchronously,and the sterilization rate increased synchronously.The D₁₀ value of bacteria,mold and yeast in angelica root powder was 3.29kGy and 2.47kGy,respectively.Mold and yeast were more sensitive to ⁶⁰Co irradiation,while bacteria were more tolerant to ⁶⁰Co irradiation.Finally,the optimal irradiation dose was determined to be 4kGy.It provides reference for the application of ethanol sterilization and irradiation sterilization in the field of traditional Chinese medicine powder sterilization.2.Comparative study on the effect of inactivation of microorganisms in angelica crude powder by different sterilization processesBy using the method of plate counting,the sterilization rate,the total amount of microorganisms,and the detection of control bacteria were investigated.The experimental results show that the angelica crude powder can meet the requirement of microorganism limit after the above four sterilization methods.Sterilization effect of damp heat sterilization sterilization（>99.7%）,ethanol（99.36%）,irradiation sterilization（99.14%）had no significant difference,dry heat sterilization is a bit poor（95.64%）,and the wet and heat sterilization,irradiation sterilization,sterilization,ethanol treatment of angelica raw powder,no bile salt resistant gram-negative bacteria staphylococcus aureus,escherichia coli,salmonella,gold detection,dry heat sterilization with bile salt resistant gram-negative bacteria,salmonella detection.3.Comparative study on sterilization technology of angelica crude powder based on"multidimensional quality evaluation"After different sterilization processes,the physical properties of angelica root powder are different,among which ethanol sterilization and irradiation sterilization have advantages in maintaining powder properties.The experimental results show that there is little difference in physical properties between irradiated samples and untreated samples.The homogeneity of the ethanol sterilized samples became worse,the fluidity increased,the hygroscopicity slightly increased,the color difference was small,and the apparent shape was basically the same.The homogeneity of the dry heat sterilized sample remains unchanged,the fluidity becomes worse,the hygroscopicity is the strongest,the powder particle surface is rough,the color is deepened;The wet and hot sterilized samples were formed into a whole block,without retaining the characteristics of powder.The physical properties of the samples were determined after crushing,showing homogeneity,poor fluidity,enhanced hygroscopicity,large color difference,and surface gelatinization of powder particles.In terms of physical properties,the advantages and disadvantages of the four sterilization methods are in the order of irradiation sterilization,ethanol sterilization,dry heat sterilization and wet heat sterilization.The chemical properties of angelica sinensis powder were different in different sterilization processes.Compared with untreated samples,the ferulic acid of ethanol sterilized samples and irradiated sterilized samples were retained 78.38%and 87.84%respectively.There was no significant difference in the extraction rate of volatile oil between the ethanol sterilized sample and irradiation sterilized sample and untreated sample,and the extraction rate of dry heat sterilized sample and wet heat sterilized sample was very low.The retention rates of the volatile oils from ethanol sterilization sample,irradiation sterilization sample,dry heat sterilization sample and wet heat sterilization sample were 99.95%,90.97%,25.75%and 40.56%,respectively.According to the qualitative experiment of polysaccharides,there are polysaccharides in irradiation sterilization sample,ethanol sterilization sample and dry heat sterilization sample,while the wet heat sterilization sample is completely destroyed.In summary,in terms of chemical properties,ethanol sterilization can ensure that the active ingredients of angelica crude powder are not destroyed.The bacteriostatic experiment of essential oil in angelica crude powder treated by four sterilization methods on four kinds of bacteria found that the bacteriostatic effect of irradiated sterilized samples was the best,the bacteriostatic circle diameter was the largest,and the MIC and MBC were consistent with the untreated samples.The results of ethanol sterilization sample and dry heat sterilization sample were followed.The bacteriostatic effect was the worst,the bacteriostatic circle diameter was the smallest,and the MIC and MBC were the largest.In terms of antibacterial activity,irradiation sterilized samples had the best effect,followed by ethanol and dry heat sterilized samples,and wet heat sterilized samples had the worst effect.Conclusion:The hygienic indexes of angelica root powder treated by four sterilization methods all meet the requirements of microbial limit.The effects of ethanol sterilization and irradiation sterilization on the components are small,while the effects of dry heat sterilization and wet heat sterilization on the components are large.The physical properties and biological activities of irradiated sterilized samples were not different from untreated samples,followed by ethanol and dry heat sterilized samples,and wet heat was the worst.Therefore,the microbial limit alone is not enough to judge the advantages and disadvantages of the sterilization process.The optimization of sterilization process and the establishment of the evaluation system of"physicochemical property and biological activity"provide reference for the optimization and evaluation of sterilization process of Chinese medicinal powder,and are of great significance for guiding the research,production and quality control of Chinese medicinal powder sterilization.